GE Healthcare SIGNA Pioneer MRI scanner control panel button design issue
GE Healthcare recalls 460 SIGNA Pioneer MRI scanners worldwide due to a control panel button design flaw. Patient Orientation button may be accidentally clicked instead of Save RX, potentially resulting in incorrect image annotation or orientation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall affecting diagnostic imaging devices where a user interface design flaw could result in incorrect image orientation or annotation. The recall addresses a risk of harm through diagnostic error, though no patient harm has been reported.
Plain-English summary
GE Healthcare is recalling approximately 460 SIGNA Pioneer whole-body magnetic resonance (MRI) scanners used for high-resolution diagnostic imaging. The systems are distributed worldwide.
The control interface includes a "Patient Orientation" button positioned near a "Save RX" button. Due to this proximity, an operator may inadvertently click the Patient Orientation button when attempting to click Save RX. Selecting and saving an incorrect patient orientation—one that does not match the patient's actual position on the scanner—alters the system's configuration before the initial 3-Plane Localizer Scan, resulting in incorrectly annotated or flipped images.
Misoriented or incorrectly annotated images may compromise diagnostic accuracy and lead to misdiagnosis. This Class II recall was initiated by GE Healthcare, the manufacturer.
The recalled product
- Product
- SIGNA Pioneer - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 460
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 14 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 14 products in this recall →Related recalls
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